# K242672: Zoom System

- Pathway: 510(k) (Traditional)
- Applicant: Imperative Care, Inc.
- Decided: Jan 14, 2025 after 130 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K183043 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
3 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211476: ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing, Imperative Care, Inc. (2021) Summary page 5.
- K210996: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing, Imperative Care, Inc. (2021) Summary page 5.

## Indications for use
The Zoom System, when used with the Zoom Aspiration Pump (or equivalent vacuum pump), is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of last known well. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

Source page: https://510kreport.com/device/K242672
Methodology: https://510kreport.com/methodology